Protriptyline hydrochloride - Generic Drug Details
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What are the generic drug sources for protriptyline hydrochloride and what is the scope of patent protection?
Protriptyline hydrochloride
is the generic ingredient in two branded drugs marketed by Epic Pharma Llc, Hikma, Sigmapharm Labs Llc, Chartwell Rx, and Teva Womens, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for protriptyline hydrochloride. Three suppliers are listed for this compound.
Summary for protriptyline hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 5 |
| NDAs: | 6 |
| Drug Master File Entries: | 5 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 58 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,069 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in protriptyline hydrochloride? | protriptyline hydrochloride excipients list |
| DailyMed Link: | protriptyline hydrochloride at DailyMed |
Recent Clinical Trials for protriptyline hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Federal University of São Paulo | Phase 4 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
| Roxane Laboratories | N/A |
Pharmacology for protriptyline hydrochloride
| Drug Class | Tricyclic Antidepressant |
Medical Subject Heading (MeSH) Categories for protriptyline hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for protriptyline hydrochloride
US Patents and Regulatory Information for protriptyline hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Epic Pharma Llc | PROTRIPTYLINE HYDROCHLORIDE | protriptyline hydrochloride | TABLET;ORAL | 202220-002 | Nov 19, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma | PROTRIPTYLINE HYDROCHLORIDE | protriptyline hydrochloride | TABLET;ORAL | 078913-002 | Sep 16, 2008 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Womens | VIVACTIL | protriptyline hydrochloride | TABLET;ORAL | 016012-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sigmapharm Labs Llc | PROTRIPTYLINE HYDROCHLORIDE | protriptyline hydrochloride | TABLET;ORAL | 090462-001 | May 3, 2010 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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